(189 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on signal acquisition and transmission, not analysis using AI/ML.
No
The device is described as acquiring signals (ECG and heart sounds) for transmission to other equipment, acting as a diagnostic tool rather than providing therapy. Its function is to perform the functions of a standard ECG electrode and an electronic stethoscope, which are diagnostic, not therapeutic, devices.
No
The device is designed to acquire heart sounds and ECG electrical signals, not to interpret or diagnose conditions based on those signals. It functions as an acquisition tool comparable to an ECG electrode and an electronic stethoscope.
No
The device description explicitly states it is a "single-use, disposable medical device" that acquires signals when "attached to the body surface." This indicates a physical hardware component is essential to its function, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Audicor™ Sensor acquires heart sounds and ECG electrical signals directly from the surface of the patient's skin. It does not analyze samples taken from the body.
- Intended Use: The intended use describes acquiring signals from the body surface, not analyzing biological samples.
- Device Description: The description focuses on its function as an ECG electrode and electronic stethoscope, both of which are external diagnostic tools.
Therefore, the Audicor™ Sensor is a medical device used for external physiological signal acquisition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
Product codes (comma separated list FDA assigned to the subject device)
DRX, JOO, DQD
Device Description
The sensor is a single use, non-sterile, disposable medical device. When used with the Audicor Adaptor the device is designed to perform the functions of both a standard resting ECG Electrode by acquiring ECG signals and an Electronic Stethoscope by acquiring heart sounds from the surface of a patients skin. The device is intended for use on the surface of an adult patient's skin in the V4 electrode position on the chest.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
V4 ECG electrode position on the chest
Indicated Patient Age Range
adult (18+ years of age)
Intended User / Care Setting
Commonly located in hospitals, doctor's offices and emergency vehicles.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sensor was tested to the applicable requirements of the performance standards, identified above, and shown to comply. Laboratory and bench testing indicates compliance Biocompatibility for the hydrogel, the primary patient contact material of the sensor, was evaluated. Test results demonstrate that the material was found acceptable for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization.
Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
0
Inovise Inc.
Attachment 3
AUG - 7 2003
Summary of Safety and Effectiveness As required by 21 CFR, part 807.92
| Submitted By: | Inovise Medical, Inc.
1025 Industrial Parkway, Suite C
Newberg, OR 97132
Fax 503.538.8868 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kendra Rathkey
Tel 503.554.4277 |
| Date Summary
Prepared: | February 14, 2003 (revised June 24, 2003) |
| Proprietary
Name: | Audicor™ Sensor |
| Common/Usual
Name: | ECG Electrode & Heart Sound Transducer. |
| Classification: | 21 CFR 870.2360 ECG Electrode, Class II, Product Code:
DRX
21 CFR 870.2860 Heart Sound Transducer, Class II, Product
Code: JOO |
| Performance
Standards: | AAMI EC12:2000 (Disposable ECG Electrodes)
AAMI EC53:1995 (ECG Cables and Lead Wires) |
| Intended Use: | The Audicor™ Sensor is a single-use, disposable medical
device designed for short duration contact (up to 1 hour) for
use at the V4 ECG electrode position to acquire both heart
sounds and ECG electrical signals when attached to the body
surface of a resting, adult (18+ years of age) patient, and to
transmit these signals to compatible electrocardiographs and
physiological recorders/monitors. Such equipment is
commonly located in hospitals, doctor's offices and
emergency vehicles. |
| Device
Description: | The sensor is a single use, non-sterile, disposable medical
device. When used with the Audicor Adaptor the device is
designed to perform the functions of both a standard resting
ECG Electrode by acquiring ECG signals and an Electronic
Stethoscope by acquiring heart sounds from the surface of a
patients skin. The device is intended for use on the surface of
an adult patient's skin in the V4 electrode position on the
chest. |
| Test Summary
& Conclusion: | The sensor was tested to the applicable requirements of the
performance standards, identified above, and shown to
comply. Laboratory and bench testing indicates compliance |
1
to the standard.
Biocompatibility for the hydrogel, the primary patient contact material of the sensor, was evaluated. Test results demonstrate that the material was found acceptable for cytotoxicity, primary skin irritation, and delayed dermal contact sensitization.
Based on the results of the engineering/design level and biocompatibility tests, it is concluded that the sensor performs as expected and compares well, in terms of overall performance to the selected predicate devices and raises no new questions with regard to safety and efficacy.
The Inovise Medical Audicor Sensor is substantially Substantial Equivalence: equivalent to the Kendall-LTP Disposable ECG electrode (K953649) and the E-Scope Electronic Stethoscope.
The table below contains the comparison of features and Technological principles of operation between the Audicor Sensor and other Characteristics: selected predicate devices.
| Feature | Inovise Medical, Inc
Audicor Sensor | Kendall
Disposable ECG
Electrode | E-Scope Electronic
Stethoscope |
|------------------------------|----------------------------------------|----------------------------------------|-----------------------------------|
| 510(k) Identifier | K030316 | K953649 | K961301 |
| Meets EC12-2000 Standard | Yes | Yes | No |
| Meets ISO 10993 Standard | Yes | Yes | Unknown |
| Disposable Device | Yes | Yes | No |
| Used on Patient Skin Surface | Yes | Yes | Yes |
| ECG Electrode Functionality | Yes | Yes | No |
| Used in V4 position | Yes | Yes | Yes and other
locations |
| Uses Conductive Hydrogel | Yes | Yes | No |
| Primary Packaging | Paper/Poly/Foil
Pouch | Paper/Poly/Foil
Pouch | Durable device |
| Acquires Heart Sounds | Yes | No | Yes |
| Uses Microphone | Yes | No | Yes |
| Frequency Range | 20 – 660 Hz
(nominal) | N/A | 10 - 2000 Hz |
| Operating Temperature | 10°C to 35 °C | Unknown | Unknown |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three stripes coming off of its head.
AUG - 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inovise Medical, Inc. c/o Mr. John C. So Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607
Re: K030316
Trade Name: Audicor™ COR Sensor Model M200 Regulation Number: 21 CFR 870.2360 and 21 CFR 870.1875 Regulation Name: Electrocardiograph Electrode and Stethoscope Regulatory Class: Class II (two) Product Code: DRX and DQD Dated: July 29, 2003 Received: July 30, 2003
Dear Mr. So:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
3
Page 2 - Mr. John C. So
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Inovise Inc.
Attachment 2
Indications for Use Statement
Applicant: Inovise Medical, Inc. K030316 510(k) Number (if known): Device Name: Audicor Sensor
Indications for use:
The Audicor™ Sensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) ✓
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030316